FDA.reportPublic FDA data

MAUDE MDR 2498838

MDR report key
2498838
Report number
3006606901-2012-00007
Event key
0
Event type
3
Date received
2012-03-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MR. BRIAN SCHMIDT
Address
1601 WEST RIVER ROAD NORTH MINNEAPOLIS MN 55411 US
Phone
612-612-6123
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CONVEEN OPTIMAMALE EXTERNAL CATHETER-UROSHEATHCOLOPLAST A/SEXJ220300100122030010013082921Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-03-2101. O

Event Narratives#

N

Patient 1

TWO PRODUCTS WERE RETURNED FOR EVALUATION. A PEEL TEST WAS PERFORMED ON THE DEVICE AND WAS WITHIN THE SPECIFICATION. THE USER STATED THAT THE INJURY OCCURRED DUE TO USING A PRODUCT THAT WAS TOO SMALL. SEEING THAT THE RETURNED PRODUCT PERFORMED ACCORDING TO DEVICE SPECIFICATIONS IT WAS CONCLUDED THAT HUMAN ERROR CONTRIBUTED TO THE EVENT.

D

Patient 1

DATE OF EVENT: BEST ESTIMATE (B)(6) 2012. ACCORDING TO THE INFORMATION RECEIVED, A USER DEVELOPED A BLEEDING SKIN WOUND AFTER USING A URISHEATH. THE USER STATED THAT THE WOUND WAS CAUSED BY USING A SHEATH SIZE THAT WAS TOO SMALL. THE USER APPLIED CREAM TO THE WOUND TO HELP IT HEAL.